BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 239868 · Received September 14, 1999

    Report

    Report Number
    1527736-1999-04883
    Event Type
    Death
    Date Received
    September 14, 1999
    Date of Event
    August 25, 1999
    Report Date
    August 27, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICES WERE USED DURING A DIAGNOSTIC LAPAROSCOPY. IT WAS REPORTED THAT USSC VERESS NEEDLE WAS USED FOLLOWED BY 511SD, THEN 2, 35OS TROCARS WERE INSERTED UNDER DIRECT VISUALIZATION. THE CASE WAS STARTED AND IT WAS REPORTED SURGEON SAW SOME BLEEDING DURING CASE, BUT DID NOT FIND SOURCE. CHECKED TROCAR SITES AND THEY WERE FINE. SURGEON USED LCSK5 TO TAKE DOWN ADHESIONS, NO BLOOD VESSELS. THERE WERE NO DIFFICULTIES OBSERVED WITH THE HARMONIC SCALPEL. ADNEXA ON BOTH SIDES REPORTEDLY HEAVY WITH ADHESIONS. DURING THIS TIME A SECOND SURGEON CAME IN AND STARTED ASSISTING DR LOST PNEUMOPERITONEUM IN THE BELLY, SAW A LOT OF POOLING BLOOD. SUCTIONED OUT. THIS OCCURRED TWO MORE TIMES DURING THE CASE. REP REPORTED DR VERBALIZED CONCERN ABOUT THE BLOOD POOLING, BUT 2ND DR CONTINUED CASE. ENDED UP TAKING DOWN ADHESIONS AND CHECKING TUBE PATENCY WITH DYE. THE LEFT TUBE WAS PATENT, THE RIGHT BLOCKED, BUT AFTER MANIPULATION OF THE RIGHT TUBE THE DYE DID FLOW THROUGH. THE CASE WAS COMPLETED AND THE TROCARS WERE REMOVED AND PT CLOSED. REP REPORTED THIS WAS THE FIRST TIME THE HARMONIC SCALPEL WAS USED AT THIS HOSP AND THIS WAS A FIRST TIME USER OF NBO TROCARS. CURRENT EVAL HAS BEEN STOPPED. ANOTHER REP WAS IN THE HOSPITAL THE NEXT DAY AND OVERHEARD THE STAFF SPEAKING OF THIS EVENT. THE PT EXPIRED, BUT NO DETAILS ARE YET AVAILABLE ABOUT THE PT'S CONDITION AND SEQUENCE OF EVENTS ONCE SHE LEFT THE O.R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCARS GCJ ETHICON ENDO-SURGERY, INC. S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death